Tazerouni Hedieh, Labbani-Motlagh Zohre, Amini Shahideh, Shahrami Bita, Sajjadi-Jazi Sayed Mahmoud, Afhami Shirin, Gholami Kheirollah, Sadeghi Kourosh
Department of Clinical Pharmacy, International Campus, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
J Diabetes Metab Disord. 2023 Jul 10;22(2):1385-1390. doi: 10.1007/s40200-023-01259-5. eCollection 2023 Dec.
This study aimed to compare individual pharmacokinetic (PK) parameters of vancomycin with predicted values from five population PK models in patients with diabetic foot infections (DFIs).
Patients with a diagnosis of DFI and an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min were included in the study. Individual PK data was carried on by collecting three vancomycin serum concentrations in a steady-state condition. Five published population-based nomograms were assumed to predict PK parameters. Optimal vancomycin exposure was considered as a trough level of 15-20 mg/L or the area under the curve over 24 h/minimum inhibitory concentration (AUC/MIC) ≥ 400.
A total of 48 samples from 16 patients were analyzed. There was a statistically significant difference between the volume of distribution (V) obtained from population methods and the individual estimations (P ≤ 0.001 in Ambrose and Burton, P = 0.010 and 0.006 in Bauer and Burton revised models, respectively). AUC/MIC ≥ 400 was achieved in 68.7% of patients while 50% had a trough level of less than 15 mg/L.
Vancomycin PK parameters, particularly individualized V, may not be predictable by population nomograms in patients with DFI and stable renal function. Moreover, the weak correlation between AUC values and trough concentrations underlines the starting practice of vancomycin AUC-based monitoring and dosing in the clinical setting.
本研究旨在比较糖尿病足感染（DFI）患者中万古霉素的个体药代动力学（PK）参数与五个群体PK模型的预测值。
纳入诊断为DFI且估计肾小球滤过率（eGFR）≥30 mL/min的患者。通过在稳态条件下收集三个万古霉素血清浓度来获取个体PK数据。假定使用五个已发表的基于群体的列线图来预测PK参数。最佳万古霉素暴露被认为是谷浓度为15 - 20mg/L或24小时曲线下面积/最低抑菌浓度（AUC/MIC）≥400。
共分析了16例患者的48个样本。群体方法获得的分布容积（V）与个体估计值之间存在统计学显著差异（在安布罗斯和伯顿模型中P≤0.001，在鲍尔和伯顿修订模型中分别为P = 0.010和0.006）。68.7%的患者达到AUC/MIC≥400，而50%的患者谷浓度低于15mg/L。
对于DFI且肾功能稳定的患者，群体列线图可能无法预测万古霉素的PK参数，尤其是个体化的V。此外，AUC值与谷浓度之间的弱相关性强调了在临床环境中基于万古霉素AUC监测和给药的起始实践。
